Health Trials

BMT-06: Study of Intensity Modulated Total Marrow Irradiation (IM-TMI)

ConditionsAcute LeukemiaMDS
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of Illinois at Chicago

About this trial

This study is being done to see if the addition of a targeted form of radiation to standard conditioning regimen will increase the amount of cancer cells that are killed off in the bone marrow and reduce the chances that your disease may return. This description is called Intensity Modulated Total Marrow Irradiation (IM-TMI).

Eligibility criteria

Qualifiers

Patient age 18-75 years

Related donor who is, at minimum, Human Leukocyte Antigen (HLA) haploidentical or mismatched unrelated donor.

Haploidentical: The donor and recipient must be identical in at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1. A minimum match of 4/8 if using HLA-A,-B,-DRB1,-Cw, or 5/10 if using HLA-A,-B,-Cw ,-DRB1, and -DQB1, will be considered evidence that the donor and recipient share one HLA haplotype.

Unrelated donors: unrelated donors who are mismatched in one or more of the following loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1,HLA-DQB1- can be included with a maximum of 4/8 or 5/10 mismatches.

Disqualifiers

a. Left ventricular ejection fraction < 40%

b. Bilirubin > 2.0 mg/dL (unless due to Gilbert's syndrome or hemolysis), and ALT and AST > 5 x ULN

c. FEV1 and FVC < 50% of predicted or DLCO <50% of predicted once corrected for anemia

d. Karnofsky score <70

Trial design

Treatments tested in this trial

  • Conditioning regimen with half-matched (haploidentical) stem cell transplant
  • Conditioning regimen with half-matched (haploidentical) stem cell transplant
  • Conditioning regimen with half-matched (haploidentical) stem cell transplant
  • Conditioning regimen with half-matched (haploidentical) stem cell transplant
  • Conditioning regimen with half-matched (haploidentical) stem cell transplant
  • Conditioning regimen with half-matched (haploidentical) stem cell transplant
  • Conditioning regimen with half-matched (haploidentical) stem cell transplant
  • Conditioning regimen with half-matched (haploidentical) stem cell transplant
  • Conditioning regimen with half-matched (haploidentical) stem cell transplant
  • Conditioning regimen with half-matched (haploidentical) stem cell transplant

Treatment groups

27 Participants
are divided into 1 treatment group

Sponsors and collaborators

University of Illinois at Chicago

Lead sponsor

Source ClinicalTrials.gov